PS-341 in Treating Patients With Metastatic Kidney Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00017329
First received: June 6, 2001
Last updated: December 13, 2009
Last verified: December 2009

June 6, 2001
December 13, 2009
April 2001
April 2004   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00017329 on ClinicalTrials.gov Archive Site
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PS-341 in Treating Patients With Metastatic Kidney Cancer
Phase II Trial of PS341 (NSC 681239) in Patients With Advanced Renal Cell Carcinoma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of PS-341 in treating patients who have metastatic kidney cancer.

OBJECTIVES:

  • Determine the efficacy of PS-341 in patients with metastatic renal cell carcinoma.
  • Determine the safety of this drug in these patients.

OUTLINE: This is an open-label study.

Patients receive PS-341 IV over 3-5 seconds twice weekly for 2 weeks. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed at 2 weeks.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 6-19 months.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Kidney Cancer
Drug: bortezomib
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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April 2004   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed renal cell carcinoma

    • Metastatic disease
  • Unidimensionally measurable disease
  • No brain metastases

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • More than 3 months

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • ALT/AST no greater than 2.5 times upper limit of normal (ULN)

Renal:

  • Creatinine no greater than 1.5 times ULN

Other:

  • No pre-existing neuropathy of grade 1 or greater
  • No other malignancy within the past 5 years, except completely resected basal cell skin cancer, unless treated with potentially curative therapy or at low risk for recurrence
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 4 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior biologic therapy and recovered
  • No concurrent biologic therapy

Chemotherapy:

  • No prior cytotoxic therapy
  • No concurrent cytotoxic therapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • At least 4 weeks since prior major surgery

Other:

  • No other concurrent anticancer therapy
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00017329
CDR0000068678, MSKCC-01032, NCI-3031
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Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Beverly Drucker, MD Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP